Cleared Traditional

OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS (K041563) - FDA 510(k) Clearance

K041563 · Glaxosmithkline Consumer Healthcare, L.P. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
78d
Days
-
Risk

K041563 is an FDA 510(k) clearance for the OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS. Classified as Saliva, Artificial (product code LFD).

Submitted by Glaxosmithkline Consumer Healthcare, L.P. (Parsippany, US). The FDA issued a Cleared decision on August 27, 2004 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Glaxosmithkline Consumer Healthcare, L.P. devices

Submission Details

510(k) Number K041563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2004
Decision Date August 27, 2004
Days to Decision 78 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 127d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 16
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K041563.
G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray
K181134 · Sunstar Americas, Inc. · Jul 2018
Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist
K173237 · Syendgen, Inc. · Mar 2018
TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges
K171542 · Dr. Harold Katz, LLC (Dba Therabreath · Mar 2018